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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 12/22/2016
Event Type  Malfunction  
Event Description

It was reported that the patient was referred for a lead and generator replacement due to high impedance being observed. During the replacement surgery it was noted that the patient's vagus nerve appeared to be damaged. The surgeon reported that the nerve appeared atrophic and discolored immediately around and under the positive and negative electrodes. The surgeon could not determine the cause of the nerve's appearance but noted that the electrodes seemed to be more degenerated than usual. The explanted lead and generator were discarded following the surgery. Therefore product analysis cannot be completed. No additional relevant information has been received to date.

 
Manufacturer Narrative

Corrected data: describe event or problem; "it was reported that during the replacement surgery the lead's electrode appeared to be corroded. After the lead and generator were replaced the new system was programmed on and the patient began coughing. The physician believed that the coughing was caused by the nerve damage sustained from the explanted lead and generator. " this information was inadvertently left off on mfg. Report #0. Corrected data: (b)(4). This information was inadvertently left off on mfg. Report #0.

 
Event Description

It was reported that during the replacement surgery the lead's electrode appeared to be corroded. After the lead and generator were replaced the new system was programmed on and the patient began coughing. The physician believed that the coughing was caused by the nerve damage sustained from the explanted lead and generator. The explanted lead and generator were received and are currently pending analysis.

 
Event Description

Analysis of the generator and lead were completed. As a part of testing the generator's output signal was monitored for a 24 hour period while it was placed in a simulated body temperature environment. During this period there were no observed variations in the output current of the generator. Analysis confirmed that the generator performed to functional specifications. It was noted that the lead was received as one portion which did not contain the electrodes or tie downs. Setscrew marks were observed on the lead's connector pin which indicated that at one time there had been proper mechanical contact between the generator and lead. Abrasions were observed in the outer tubing and it appeared that the cause of these abrasions were related to wear. A continuity check was performed on the returned lead portion and no discontinuities were identified. The analysis was unable to confirm the presence of a fracture in the portion of the lead that had been received.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6300905
Report Number1644487-2017-03135
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/16/2005
Device MODEL Number302-20
Device LOT Number009157
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/02/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/17/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/03/2017 Patient Sequence Number: 1
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